Google relaxes ban on stem cell therapy ads – The Verge

Google will allow ads for stem cell treatments that are approved by the US Food and Drug Administration a change from its previous policy, which banned all ads for this experimental category of medical care. The policy update was first reported by Gizmodo and will go into effect in July.

The company said in the policy update that it will also allow cell or gene therapy ads that are exclusively educational or informational in nature, even if they reference products or applications that are not approved by the FDA. Its not clear how Google would define educational or informational or what type of advertisements would be allowed under that umbrella.

Stem cell therapy is a broad term for medical treatments that use stem cells, which can develop into any cell type. There are some evidence-based applications for the cells, like to treat some cancers, and there are around two dozen FDA-approved cell- and gene-therapy products (which Googles new policy would allow ads for).

But most uses for stem cells are unproven, experimental, and can be dangerous. Clinics claim the cells, taken from donated umbilical cords or from patients fat, can treat things like joint pain or eye conditions. People have developed infections and died after getting those types of procedures. The FDA has tried to crack down on businesses offering these types of procedures, but theyve proliferated over the past few years.

Googles initial ban on stem cell ads hasnt done much to keep the clinics from popping up in search, Paul Knoepfler, a professor at the UC Davis School of Medicine, wrote in Stat in March. Even if they cant advertise, the companies have designed websites that appear at the top of search results for searches related to stem cells above more reputable medical resources, like the National Institutes of Health.

These companies are savvy and have been able to skirt policies to push out their products even in the face of a total ban. Now, that ban is set to relax, opening up new avenues for groups to distribute information. Googles continuing stem cell problem is emblematic of a serious, broader problem with unproven biomedical offerings the company needs to address, Knoepfler wrote.

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Stem cell therapy offers a new hope to repair brain damage in newborns – Yahoo News UK

A few hours after Tom (not his real name) was born, he became restless and did not want to be breastfed. His mother noticed that his left arm and leg were shaking rhythmically something was not right.

Tom was immediately transferred to the neonatal intensive care unit. An MRI scan revealed that he had suffered a severe stroke. Doctors told Toms parents that there was no treatment they could give the child. He would probably be disabled.

Most people think of stroke as something that mainly affects the elderly, but it can also occur in newborn babies. These perinatal strokes happen when one of the major arteries to the brain becomes blocked, leading to a lack of blood supply and hence oxygen to certain brain areas. About one in 5,000 newborns have a stroke. It usually happens in the first few days after they are born.

Most of the babies will have problems later in life, with the severity of the problems depending on which brain areas were injured. These problems can include muscle tightness in the arms and legs (cerebral palsy), behaviour problems, learning difficulties and epilepsy.

No therapy exists for newborns with stroke. Researchers, including our own team at University Medical Center Utrecht, have been working on new treatments, one of which involves stem cells.

Stem cells have the ability to turn into many different cells in the body, and they are little factories of several growth factors (proteins that stimulate the growth of specific tissues). The theory is that if we can get stem cells into the damaged part of a babys brain, the stem cells growth factors will stimulate the brain to repair itself.

Earlier studies in animals showed that injecting stem cells into the brains of newborn mice with stroke dramatically reduced the amount of brain damage and disability they suffered. The experiments showed that the treatment was safe and had no side-effects in the mice. These animal studies gave us hope that the treatment would work in newborn babies, too, preventing a lifetime of disability.

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But how do you deliver stem cells to a babys brain without having to use needles or surgery? We decided to try an intranasal route (through the nose), which was tested in mice. After we delivered the stem cells intranasally, the cells travelled rapidly and specifically to the injured brain areas. The injured brain area sends out alarm signals which guide the stem cells to the right spot in the brain.

Once the stem cells arrived at the damaged area, they secreted growth factors that boosted the repair systems of the mices brains. Within a few days, the stem cells were broken down and not traceable in the brain any longer. After several experiments with this method, we concluded that dripping stem cells in the nose is the safest and most efficient way to deliver them to the brain.

After many years of laboratory research, we have finally tested the treatment in babies. The results have been published in The Lancet Neurology.

Baby Tom, mentioned earlier, was the first baby to participate in the study and received stem cells within a week of being born. To ask parents to enrol in an experimental therapy in the first week of their newborn childs life is a very delicate process.

After we had a long conversation with his parents, they decided to let their son take part in the study. He received stem cells via nose droplets, a procedure that took only several minutes. Afterwards, Tom was monitored closely for a few days before he went home.

We treated ten newborns who were transferred from hospitals across the Netherlands to the University Medical Center Utrecht after suffering from a stroke. In all ten newborns, the stem cell droplets were administered without any complications. There was one baby who had a mild fever after the treatment, which quickly cleared up on its own.

A follow-up MRI scan of the brain made three months after the stroke showed less injury than expected, possibly because of the stem cells. At four months, the treated babies, including Tom, performed well when the quality of their movements was tested. When the children are two years old, we will check their development again.

We are now looking for opportunities to proceed with a randomised controlled trial (the gold standard for medical studies) to prove that stem cell therapy can effectively repair brain injury after perinatal stroke.

The discovery of a new and safe therapy with stem cells also opens up opportunities for other babies with brain injury, such as babies who are born too early, or babies that suffer from a lack of oxygen during birth (perinatal asphyxia). Stem cell therapy gives hope to the most vulnerable patient group, with possible lifelong benefits.

This article is republished from The Conversation under a Creative Commons license. Read the original article.

The Conversation

Nienke Wagenaar receives funding from Utrecht University, Wilhelmina Children's Hospital Research Fund, Royal Netherlands Academy of Arts and Sciences and the Research Training Centre of the Hospital for Sick Children. For previous work, including the PASSIoN study, she received funding from the Netherlands Organisation for Health Research and Development (ZonMW).

Lisanne Baak receives funding from the Netherlands Organisation for Health Research and Development (ZonMW).

Niek van der Aa receives funding from the Wilhelmina Children's Hospital Research Fund, Health Holland, Utrecht University and the Vaillant Fund.

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Stem cell therapy offers a new hope to repair brain damage in newborns - Yahoo News UK

$83 Bn Regenerative Medicine Markets – Global Opportunity Analysis and Industry Forecast, 2021-2022 & 2030 – ResearchAndMarkets.com – Business…

DUBLIN--(BUSINESS WIRE)--The "Regenerative Medicine Market by Product Type, Material, Application and End user (Hospitals, Ambulatory Surgical Centers, and Others: Global Opportunity Analysis and Industry Forecast, 2021-2030" report has been added to ResearchAndMarkets.com's offering.

The regenerative medicine market size was valued at $10,107.32 million in 2020, and is estimated to reach $83,196.72 million by 2030, growing at a CAGR of 23.4% from 2021 to 2030.

Regenerative medicine is a process of replacing human cells, tissues or organs to restore or establish normal function. It is field that brings together experts in biology, chemistry, genetics and medicine. This is a promising field which working to restore structure and function of damaged tissues and organs.

It includes cell therapy involves the use of cellular materials such as stem cells, autologous cells, xenogeneic cells, and others, for the therapeutic treatment of patients. Cell therapy is used to replace damaged cells, deliver therapies to target tissues/organs, stimulate self-healing, and various other applications in regenerative medicine.

The major factors boosting the regenerative medicine market growth include technological advancements in tissue and organ regeneration, increase in prevalence of chronic diseases and trauma emergencies, prominent potential of nanotechnology, and emergence of stem cell technology.

In addition, increase in incidence of degenerative diseases and shortage of organs for transplantation are expected to boost the growth of the market. The prominent potential of regenerative medicine to replace, repair, and regenerate damaged tissues and organs has fueled the market growth. In addition, technological advancements in regenerative medicine production and advancement in the stem cell therapy procedures propel the growth of the market.

Rise in prevalence of musculoskeletal diseases and increase in dermatological treatments propel the growth of the market. Moreover, utilization of nanomaterial's in wound care, drug delivery, and immunomodulation has opened growth avenues for the regenerative medicine market.

However, stringent regulations, operational inefficiency, and high cost of regenerative medicine treatment are key factors that hinder the market growth. Furthermore, advancements in stem cell technology and increase in R&D activities in the emerging economies are expected to fuel the market growth during the forecast period. Developed nations have adopted technological advancements in tissue engineering and regenerative medicine sectors, which help in the expansion of the global market.

Moreover, rise in development of pharmaceutical and medical device industries and improvement in healthcare spending are anticipated to drive the growth of the regenerative medicine market. In addition, increase in demand for regenerative medicine led to development of innovative technologies in the healthcare sector, thereby propelling growth of the market.

Moreover, initiatives taken by governments for development of advanced stem cell therapies and development of the healthcare sector for manufacturing of regenerative medicine are the key factors that boost growth of the market. Furthermore, surge in geriatric population, who are more vulnerable to chronic disease, propels the market growth.

KEY MARKET PLAYERS

KEY MARKET SEGMENTS

By Product Type

By Material

By Application

By End User

By Region

For more information about this report visit https://www.researchandmarkets.com/r/qek5u

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CU Anschutz center for cell-based therapy gets $200 million expansion – The Denver Post

An existing center on the University of Colorados Anschutz Medical Campus that helps develop treatments based on patients own cells is getting a $200 million boost, with the hope of getting those treatments to the public faster.

Chancellor Don Elliman said the Anschutz campus and the Gates Frontiers Fund will each invest $20 million per year over the next five years to turn the existing Gates Center for Regenerative Medicine into the significantly larger Gates Institute.

The Gates Frontiers Fund is affiliated with the Gates Family Foundation, a Colorado-based nonprofit,and is not connected to Bill Gates foundation.

The fund and the campus in Aurora also have partnered on a manufacturing facility that reprograms patients immune cells to fight certain cancers. Elliman said they dont expect to need a new building for the institutes expanded work.

Regenerative medicine is a broad term for treatments that try to harness the bodys ability to fix itself. That could involve reprogramming cells to replace dying tissue or fight cancer, or therapies that insert a healthy gene to replace a defective version thats causing disease.

Its early enough in the process that the institutes leadership hasnt chosen specific focus areas under the regenerative medicine umbrella.

Most of the $200 million will go toward hiring scientists, as well as support personnel to help both the new researchers and those already working on campus, Elliman said.

Once the institute is up and running, it will bring in new federal grants to support research and investment from biotech firms that can bring the treatments to market, he said.

This investment is really a seed investment, he said.

Dr. Terry Fry, the institutes executive director, said its meant to help scientists with ideas that show promise in the lab to take the steps toward testing them in humans.

The process of manufacturing treatments and getting trials approved is more complex for biologic therapies than for standard drugs, he said.

Theres a stage in the development of that sort of project where investigator-scientists run up against a brick wall, he said. A lot of the role that I see the institute playing is removing those barriers.

Fry, a pediatric oncologist, was one of the first researchers who worked on chimeric antigen receptor T-cell (CAR-T) therapy the immune cell reprogramming therapy. It was approved first for children with leukemia, but now is also used for adults and for other blood cancers, like lymphoma and myeloma. He declined to name specific projects the institute would work on, but said potential improvements to CAR-T could be within its scope.

The therapy takes a kind of T-cell that kills cells infected with viruses or bacteria, and gets it to attack cancerous cells instead. While it has improved survival for people with certain blood cancers, it doesnt work well against solid tumors at this point. It also requires taking T-cells from each patient to produce their own treatment, which is expensive and slows down the process. Researchers are working on how to make CAR-T work for more people, and to create an off the shelf option, Fry said.

Another general area the institute could work on is growing cells to replace ones that have died or are defective, Fry said. Much of that work involves adult stem cells that have been coaxed back into an earlier form, when they could become almost any type of cell under the right conditions.

For example, if the stem cells can be primed to turn into cells producing insulin, that could help patients with Type 1 diabetes, which is caused when the insulin-producers die, he said.

It is really remarkable technology, he said.

The institute wont take down every hurdle to bringing new treatments to patients, Fry said. Manufacturing and distributing at a large scale will require partnerships with biotech firms, which fortunately are setting up in the Denver area in increasing numbers, he said.

I think this is the right time and exactly the right part of the country for this type of institute, he said.

Diane Gates Wallach, one of the Gates funds co-trustees, said the new institute will further her fathers goal of speeding up the process of getting new discoveries into clinical practice, so patients can benefit. Since the Anschutz campus includes researchers and two hospitals, it made sense to invest there, she said in a news release.

It takes a dynamic, innovative medical ecosystem for an institute like this to thrive and be successful, she said.

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CU Anschutz center for cell-based therapy gets $200 million expansion - The Denver Post

Cord Blood Banking: Benefits, Cost, and Process – Healthline

If you are a new or expectant parent, youve probably heard about the option of banking your babys cord blood at birth. The topic can be confusing, and you may have many unanswered questions.

You may be unsure exactly what cord banking involves, why people choose to bank their infants blood, whether its worth it to do so, and how much it costs to bank cord blood.

Heres a simple breakdown of the potential benefits of cord blood banking and how to decide if its right for your family.

At birth, your newborns placenta and umbilical cord contain blood that is rich with potentially lifesaving stem cells. This blood can be removed, stored, and used down the road to treat various diseases and conditions.

Healthcare professionals do not remove cord blood directly from babies or birthing parents. Rather, it comes from the umbilical cord and placenta themselves, according to the American College of Obstetricians and Gynecologists (ACOG).

The stem cells in umbilical cords and placentas are called hematopoietic stem cells. In people with certain health conditions, they can be used to produce healthy new cells and replace damaged cells.

Stem cells are used to treat over 70 types of diseases, according to ACOG. These include:

You might choose to bank your newborns cord blood for several reasons.

First, you may choose to do so if you have a family member with a medical condition that might benefit from stem cell donation. Alternatively, you might want to donate your babys blood to help another person in need of stem cells.

One myth about cord banking is that you child can use the cord blood down the line, should they develop a serious medical concern. This type of transfer where a persons own cord blood is used to treat their health condition is called an autologous transplant.

ACOG notes that autologous transfers are rare.

If your child has a genetic disease, for example, treating them with their own stem cells wouldnt help because these stem cells contain the same genes as the cells that are involved in the disease. Similarly, your own childs stem cells cant be used to treat cancers such as leukemia.

Instead, most cord blood transplants are allogeneic.

This means that your childs stem cells would be used to treat another child or adult. It would require a strong match between the stem cell recipient (the person using the stem cells) and the stem cell donor (your child).

The benefits of cord blood banking depend on your purpose and where you are storing your childs cord blood.

If you are storing your childs blood at a private institution, you may be able to use the stem cells to directly benefit a family member in need, including a close family member or your childs sibling.

Storing your babys cord blood in a public facility has benefits, too. Stem cells can help treat people with many types of health conditions, including cancers and certain metabolic and immunologic conditions, according to the Health Resources & Services Administration.

There are many advantages to using stem cell transplants for treating medical conditions rather than using bone marrow transplants.

According to ACOG, these benefits include:

If you want to have your newborns cord blood collected, you should inform your OB-GYN or birthing professional, such as a midwife, and the hospital or facility where you will give birth. They may need to order special equipment or a cord collecting kit.

Usually, you will need to inform your healthcare team of your choice to bank your infants blood about 6 weeks in advance of your due date. Youll also need to be sure youve signed all the required consent forms.

Cord blood extraction happens in the hospital after birth and after a healthcare professional has clamped and cut the umbilical cord. They will then use a needle to draw blood out of the cord and store in a designated bag.

The entire process is quick about 10 minutes and does not involve direct contact with your baby.

Sometimes, cord blood extraction isnt possible. Reasons for this may include:

After collection, cord blood must be stored very carefully to ensure that its quality is preserved. Each facility has its own protocols and procedures for how this is done.

The Academy of American Pediatrics (AAP) explains certain accrediting institutions oversee the regulation of cord blood storage and cautions that some private cord blood banks may not meet all these standards.

Before agreeing to have your childs cord blood stored at a private facility, you may want to find out:

Cord blood bank accrediting institutions include:

Before considering cord blood donation, its important for you to understand the difference between private and public banks. Heres what to know:

Private banks are usually used by parents who believe that their childs cord blood may be helpful to a family member who has a medical condition.

They require you to pay on an ongoing basis for your childs cord blood to be stored.

Not all private banks are accredited or regulated in the same way that public banks are.

Public banks are free and supported by government or private funds.

Currently, there is very little evidence that storing your childs blood will help your own child fight a medical condition in the future. In fact, if your child needs stem cells to treat a condition, its more likely that they will receive a donation from a public cord bank.

When you donate to a public cord bank, you do not get to decide who will use your childs blood. You are essentially donating your childs cord blood to help a person in need.

Public cord banks are heavily regulated, and cord blood from these banks is used more frequently than cord blood from private banks. In fact, blood from public banks is used 30 times more frequently than from private banks.

Most major health organizations including the Academy of American Pediatrics and the American College of Obstetricians and Gynecologists recommend public cord blood banking.

Another reason these organizations recommend using public cord blood banks is that they are consistently and well regulated.

Cord blood banking at a public cord bank is free, and you will not have to pay any costs if you donate. These institutions are usually supported by federal funds or receive private funding.

On the other hand, private blood cord banks charge fees, and you must pay these fees for the entire time your childs cord blood is stored in these facilities.

Private cord banks generally charge an initial fee for collecting and processing cord blood. After these initial fees, you will also pay annual fees for ongoing storage. Private cord blood banks vary in their fee amounts, but they average about $2,000 for initial fees and between $100 and $175 each year for annual storage fees, per the AAP.

There are many benefits to banking cord blood. But how you do it depends on several factors, including your familys medical needs and your financial situation.

Almost anyone can choose to donate their infants cord blood to a public bank. Doing so may help many people. While most medical institutions do not recommend private cord banking, this may be the right choice for you if you have a family member who might use the cord blood you bank to treat a health condition.

Either way, its a good idea to speak with your healthcare professional before deciding on whether to bank your babys cord blood. They can also advise you on the best way to do it and which type of blood bank may best meet your needs.

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Cord Blood Banking: Benefits, Cost, and Process - Healthline

Orchard Therapeutics Announces Presentations at ASGCT 2022 Showcasing Potential of HSC Gene Therapy in Neurodegenerative Disorders and Beyond – Yahoo…

Orchard Therapeutics (Europe) Limited

BOSTON and LONDON, May 10, 2022 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today outlined seven presentations from across its platform to be featured at the American Society of Gene & Cell Therapy (ASGCT) 25th Annual Meeting taking place May 16-19 in Washington, D.C. Featured presentations include updated results on the OTL-203 clinical program for mucopolysaccharidosis type I Hurler syndrome (MPS-IH), as well as several accepted abstracts highlighting preclinical work demonstrating the applicability of HSC gene therapy to potentially address other neurodegenerative and CNS-related conditions, including frontotemporal dementia (FTD).

The breadth of data to be presented at ASGCT represent notable progress in our efforts to realize the full potential of our HSC gene therapy platform, particularly for neurodegenerative and CNS-related disorders, said Leslie Meltzer, Ph.D., chief medical officer of Orchard Therapeutics. Our programs continue to demonstrate the unique ability of the HSC gene therapy approach to enable broad distribution of gene-corrected cells and localized delivery of therapeutic enzymes and proteins at clinically relevant concentrations not achievable by other modalities.

The full presentation details are as follows:

Monday, May 16

Presentation title: Up to 10.5 years of follow-up in 17 subjects treated with hematopoietic stem and progenitor cell lentiviral gene therapy for Wiskott-Aldrich syndrome Time: 2:15-2:30 p.m. EDT Lead Author: Dr. Francesca Ferrua Type: Oral Abstract Session Session Title: Gene and Cell Therapy Trials in Progress

Presentation title: Targeting CX3CR1 gene to improve microglia reconstitution and transgene delivery into the CNS upon hematopoietic stem and progenitor cell transplant Time: 4:00-4:15 p.m. EDT Lead Author: Dr. Annita Montepeloso Type: Oral Abstract Session Session Title: Hematopoietic Stem Cell Gene Therapy

Presentation title: Hematopoietic reconstitution and lineage commitment in HSC-GT patients are influenced by the disease background Time: 5:30-6:30 p.m. EDT Lead Author: Dr. Andrea Calabria Type: Poster Session Session Title: Hematologic and Immunologic Diseases I

Presentation title: Development of an ex vivo gene therapy for frontotemporal dementia (FTD) Time: 5:30-6:30 p.m. EDT Lead Author: Dr. Yuri Ciervo Type: Poster Session Session Title: Neurologic Diseases I

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Wednesday, May 18

Presentation title: Clinical trial results of hematopoietic stem cell gene therapy for mucopolysaccharidosis type I Hurler Time: 8:00-8:26 a.m. EDT Lead Author: Maria Ester Bernardo Type: Scientific Symposium Session Title: Inborn Metabolic Issues

Presentation title: Pathophysiological mechanisms of bone damage and bone cross correction in MPSIH gene therapy Time: 5:30-6:30 p.m. EDT Lead Author: Dr. Ludovica Santi Type: Poster Session Session Title: Musculo-skeletal Diseases

Presentation title: Innovative and regulated lentiviral promoter for the gene therapy of neurodegenerative diseases Time: 5:30-6:30 p.m. EDT Lead Author: Dr. Yuri Ciervo Type: Poster Session Session Title: Neurologic Diseases III

About Orchard Therapeutics At Orchard Therapeutics, our vision is to end the devastation caused by genetic and other severe diseases. We aim to do this by discovering, developing and commercializing new treatments that tap into the curative potential of hematopoietic stem cell (HSC) gene therapy. In this approach, a patients own blood stem cells are genetically modified outside of the body and then reinserted, with the goal of correcting the underlying cause of disease in a single treatment.

In 2018, the company acquired GSKs rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Today, Orchard is advancing a pipeline spanning pre-clinical, clinical and commercial stage HSC gene therapies designed to address serious diseases where the burden is immense for patients, families and society and current treatment options are limited or do not exist.

Orchard has its global headquarters in London and U.S. headquarters in Boston. For more information, please visit http://www.orchard-tx.com, and follow us on Twitter and LinkedIn.

Availability of Other Information About Orchard Investors and others should note that Orchard communicates with its investors and the public using the company website (www.orchard-tx.com), the investor relations website (ir.orchard-tx.com), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchards investor relations website and may include additional social media channels. The contents of Orchards website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking Statements This press release contains certain forward-looking statements about Orchards strategy, future plans and prospects, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may be identified by words such as potential, continue to, and future or similar expressions that are intended to identify forward-looking statements. Except for statements of historical fact, information contained herein constitutes forward-looking statements and may include, but is not limited to, Orchards expectations regarding the safety and efficacy of its products and product candidates. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchards control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, these risks and uncertainties include, without limitation, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies or clinical trials of Orchards product candidates will not be repeated or continue in ongoing or future studies or trials involving its product candidates and the severity of the impact of the COVID-19 pandemic on Orchards business, including on preclinical and clinical development, its supply chain and its commercial programs. Given these uncertainties, the reader is advised not to place undue reliance on such forward-looking statements.

Other risks and uncertainties faced by Orchard include those identified under the heading Risk Factors in Orchards most recent annual or quarterly report filed with the U.S. Securities and Exchange Commission (SEC), as well as subsequent filings and reports filed with the SEC. The forward-looking statements contained in this press release reflect Orchards views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

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